Interpace Diagnostics Announces Additional Coverage of Thyroid Tests

Four More Blue Cross Blue Shield Plans to Cover ThyGenX® and ThyraMIR® Representing Over 5 million New Members with Coverage

PARSIPPANY, N.J., March 08, 2018 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or “the Company”), a fully integrated commercial and bioinformatics company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management announced today that four additional Blue Cross Blue Shield plans have agreed to cover both of Interpace’s proprietary thyroid tests: ThyGenX and ThyraMIR.  The plans include Blue Cross Blue Shield of Arizona; Blue Cross Blue Shield of South Carolina; Wellmark Blue Cross Blue Shield of Iowa; and Wellmark Blue Cross Blue Shield of South Dakota. These four plans combined represent over 5 million members who now have coverage for the Company’s molecular thyroid tests. 

Blue Cross Blue Shield of Arizona and Blue Cross Blue Shield of South Carolina are two of the remaining independent Blue Cross Blue Shield plans, whereas Wellmark is the parent Company of Blue Cross Blue Shield of Iowa and South Dakota, with Wellmark representing the largest plan in the State of Iowa.

This follows the Company’s recent announcement that Horizon Blue Cross Blue Shield of New Jersey, one of the nation’s largest BCBS plans with 3.8 million members, began covering both of our thyroid tests in January 2018. With the addition of these plans’ members, ThyGenX and ThyraMIR are now covered for over 280 million patients nationwide, including through Medicare, National, Medicare Advantage, and Regional health plans. These decisions, among that of several other Blue Cross Blue Shield plans across the country, follow a recent technology assessment review that found ThyGenX and ThyraMIR demonstrate clinical utility and have a favorable impact on patient outcomes.   

Jack E. Stover, President and CEO of Interpace Diagnostics stated, “The coverage of ThyGenX and ThyraMIR by these additional Blue Cross Blue Shield plans is further evidence that we have met the clinical utility threshold required to secure reimbursement for these tests. We are pleased that these plans have joined the growing list of health plans that cover ThyGenX and ThyraMIR and that their more than 5 million members will now have access to the benefits they offer.”

According to the American Cancer Society, thyroid cancer is the most rapidly increasing cancer in the U.S., tripling in the past three decades. Most physicians have traditionally recommended thyroid surgery where thyroid nodule biopsy results are indeterminate, not clearly benign, or malignant, following traditional cytopathology review; however, 70%-80% of these surgical outcomes are ultimately benign.  Molecular testing using ThyGenX and ThyraMIR has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.

The ThyGenX and ThyraMIR combination we believe represents the only test in the market that includes the rule-in properties of next-generation sequencing of a patient’s DNA and RNA along with the rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, greater than 90% of the Company’s ThyGenX cases are reflexed to ThyraMIR for additional assessment.  The Company first launched ThyGenX in 2014 followed by ThyraMIR in April 2015, making both tests available to Endocrinologists, Endocrine Surgeons, and Pathologists throughout the country.  Since then, the Company has conducted over 15,000 ThyraMIR tests for nearly 400 physicians and hospitals nationwide and has initiated two studies to further demonstrate the test’s clinical validity and utility, including an ongoing study with a consortium of leading institutions in New York City and a multi-site, national Registry of cases already tested using ThyGenX and ThyraMIR.   

About Thyroid Nodules, ThyGenX and ThyraMIR Testing

According to the American Thyroid Association, approximately 20% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.

ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules.  The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.

ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyraMIR is the first microRNA gene expression classifier.  MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs.  Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers. 

About Interpace Diagnostics Group, Inc.

Interpace Diagnostics is a fully integrated commercial and bioinformatics company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has four commercialized molecular tests; PancraGEN™ for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay and RespriDx™ is a molecular test that differentiates between new primary lung tumors and metastasis by identifying the unique molecular fingerprint of a tumor using a series of tumor markers and loss of heterozygosity (LOH).  Interpace Diagnostics' mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company's future financial and operating performance, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the Company's ability to adequately finance the business, the market's acceptance of its molecular diagnostic tests, its ability to retain or secure reimbursement, its ability to secure additional business and generate higher profit margins through sales of its molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments and its ability to maintain its NASDAQ listing. Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and other SEC filings. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

CONTACTS:

Interpace Diagnostics
Investor Relations:
Paul Kuntz – Redchip
paul@redchip.com

Released March 8, 2018